Featured Articles

December 2009

Data and Content Migrations: Minimizing the Risk

Compliance and business risk plays a significant role in the implementation methodologies of corporate information systems. Further, the compliance and business risks associated with these corporate information systems are, in general, well known. However, as part of the implementation process many of these information systems will be populated with legacy data. The compliance and business risks associated with migrating this legacy data and content into a new system are not necessarily understood. In this context, risks associated with data migrations are a direct result of migration error. Further, industry testing strategies to mitigate such risk, or more specifically data migration error, lack consistency and are far from deterministic. This is the first of two articles that present some thoughts and recommendations on how such a testing strategy can be designed.

The Challenges of Change Control

Maintaining the validated state of equipment, utilities and processes is a basic component of a quality system as defined in current regulations and to that end, changes made to these items need to be documented through a formal change control program. The composition of a change control program can be as different as companies themselves, but the basic expectations of such programs can be summarized.

Please Don't Call Them CAPAs

I've long been troubled by the ubiquitous acronym used to refer to corrective action: CAPA. My gut reaction borders on the irrational. Most of you reading this have heard of or read about or used the acronym hundreds of times. And you're probably wondering why the two syllables CA-PA should produce such an extreme reaction - especially in someone who spends a great deal of her time teaching people about both corrective action and preventive action. The short answer is simple: They're two separate processes that have been mashed together resulting in a diminution in the effectiveness of both.

Did you know that ASQ's recent Annual Salary Survey shows that quality professionals' average salary has risen despite recent economic setbacks? Why is it that quality professionals have "escaped" the jaws of an unpleasant economy? There are a variety of contributing factors but when all is said and done quality professionals with certifications and experience are coming out on top."Read More